Dolex
- Product NDC
- 55758-026
- 11-digit product format
- 557580026
- Labeler code
- 55758
- Product ID
- 55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dolex
- Brand name suffix
- Children Pain and Fever
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f9158463-aeb1-5de0-e053-6294a90a748b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-026-04 | DolexChildren Pain and Fever | 1 in 1 BOX | SUSPENSION | 1 | 3 | |
| 55758-026-04 | DolexChildren Pain and Fever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dolex Children Pain and Fever | ACETAMINOPHEN | Pharmadel LLC | f9158463-aeb1-5de0-e053-6294a90a748b | 2024-03-04 | Warnings | M013 55758-026 |
| SEDALMEX FORTE | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Belmora LLC | 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d | 2024-02-28 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AMERISOURCE BERGEN | 2b923a97-836c-4dac-a8c0-3047a35fb62e | 2024-02-23 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | BJWC (Berkley & Jensen / BJ's) | b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 | 2024-02-22 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 31a41976-7f65-42d7-acf5-de9c2c5ca58e | 2024-02-20 | Warnings | M013 |
| Publix Fast Relief Effervescent - Original Flavor | ASPIRIN | PUBLIX SUPER MARKETS INC. | 0a342f72-45fd-3e12-e063-6394a90ae33e | 2024-02-16 | Warnings | M013 |
| Equaline Effervescent Pain Reliever | ASPIRIN | UNITED NATURAL FOODS, INC. DBA UNFI | 0761299a-e913-7665-e063-6394a90a6003 | 2024-02-16 | Warnings | M013 |
| TopCare Effervescent Pain Relief | ASPIRIN | TOPCO ASSOCIATES LLC | 075f36e1-110c-e839-e063-6294a90a89d7 | 2024-02-16 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 115d0b4f-6f0f-79a9-e063-6394a90ab18a | 2024-02-14 | Warnings | M013 |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | e1799765-c247-42b4-ad6a-8ba7d136abf2 | 2024-02-06 | Warnings | M013 |
| Panadol Cold and Flu NonDrowsy | ACETAMINOPHEN AND PHENYLEPRINE HCL | Haleon US Holdings LLC | f626ab17-01c9-4493-ba9e-0c8c11146384 | 2024-02-06 | Warnings | M013 |
| PANADOL Extra | ACETAMINOPHEN AND CAFFEINE | Haleon US Holdings LLC | e5c2d88a-d903-4ca0-b895-f27e791dfc4e | 2024-02-06 | Warnings | M013 |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b | 2024-02-06 | Warnings | M013 |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | 9d384e88-5c11-4600-ac6c-a38371570138 | 2024-02-06 | Warnings | M013 |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | 95801755-db54-4ad7-bec1-52671914f6ca | 2024-02-06 | Warnings | M013 |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 01e7dddb-755c-4745-b701-edcdb6209064 | 2024-02-06 | Warnings, Adverse reactions | M013 |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 9064943f-836f-4853-b6f2-2c4879941eeb | 2024-02-02 | Warnings | M013 |
| Quality Choice Effervescent Pain Relief | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 079af5d7-1be8-2a93-e063-6294a90a496d | 2024-02-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin | ACETAMINOPHEN | Proficient Rx LP | 4c84948d-3a95-4c53-8529-7e7b9d8bb6df | 2024-02-01 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55758-026-04 | 55758002604 | 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE | 1 bottle | 2023-01-01 | No | No | Current |